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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047997
Receipt No. R000054700
Scientific Title Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/08

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Basic information
Public title Impact of music therapy in post-stroke aphasia patients
Acronym Impact of music therapy in post-stroke aphasia patients
Scientific Title Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Scientific Title:Acronym Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Region
Japan

Condition
Condition Post-stroke aphasia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An initial investigation into whether listening to music with lyrics improves aphasia in subacute stroke patients, and if so, in what aphasia classifications and in what symptoms of aphasia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in WAB-AQ(Western Aphasia Battery-Aphasia quotient) before and after the 3-month intervention period
Key secondary outcomes The change in each subset score of the WAB(Western Aphasia Battery) before and after the 3-month intervention period

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Three months of free listening to music with lyrics of the patient's choice for at least one hour per day. Every two weeks, a 15-minute interview with a physician or nurse to check and improve adherence to music listening
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria First stroke patients admitted to the Recovery Rehabilitation Unit of Murayama Medical Center, within 60 days of onset, with aphasia scoring 4 or less on the severity scale of the Boston Diagnostic Aphasia Evaluation, whose attending physician deems them appropriate and who have given written consent
Key exclusion criteria Native language is not Japanese, severe hearing impairment
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Toshiyuki
Middle name
Last name Suzuki
Organization Saiseikai Higashikanagawa Rehabilitation Hospital
Division name Department of Rehabilitation medicine
Zip code 221-0822
Address 1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa
TEL 045-324-3600
Email someguya617@gmail.com

Public contact
Name of contact person
1st name Toshiyuki
Middle name
Last name Suzuki
Organization Saiseikai Higashikanagawa Rehabilitation Hospital
Division name Department of Rehabilitation medicine
Zip code 221-0822
Address 1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa
TEL 045-324-3600
Homepage URL
Email someguya617@gmail.com

Sponsor
Institute Murayama Medical Center, department of Rehabilitation medicine
Institute
Department

Funding Source
Organization Murayama Medical Center, department of Rehabilitation medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Murayama Medical Center
Address 2-37-1 Gakuen, Musashimurayama, Tokyo
Tel 042-561-1221
Email 218-murayamahome@mail.hosp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2022 Year 06 Month 15 Day
Date of IRB
2022 Year 03 Month 15 Day
Anticipated trial start date
2022 Year 06 Month 15 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 08 Day
Last modified on
2022 Year 06 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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